Investigating urinary microbiome differences in bladder cancer and healthy men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the differences in the urinary microbiome among adult men diagnosed with bladder cancer, those with benign urinary diseases, and healthy counterparts. It focuses on identifying variations in bacterial diversity and richness, which may indicate a relationship between the microbiome and bladder cancer. The study will analyze bacterial profiles based on tumor stage and assess the presence of specific bacterial genera associated with bladder cancer. By understanding these differences, the research seeks to clarify the role of the urinary microbiome in bladder cancer pathology.

Why it matters

Who can join: the full rules

Inclusion Criteria (Bladder Cancer Patients):

* Diagnosis of bladder cancer
* Negative urine culture
* Histological confirmation of urothelial carcinoma
* Patients undergoing radical cystectomy

Exclusion Criteria:

* Presence of other neoplasias
* History of previous BCG therapy
* Use of indwelling catheter
* Active antibiotic treatment with two months prior to participation
* History of sexual transmitted diseases
* Presence of chronic intestinal inflammation
* Previous neoadyuvant therapy

Inclusion Criteria Controls No-Pathologic/Healthy):

\- Controls will be collected from men within the specified age range. Eligible controls may be drawn from the institution's personnel attending the occupational medicine department or in service in the Institute.

Exclusion Criteria:

* Diabetes
* Chronic Kidney Disease
* Cardiac disease
* Hepatic disease

Inclusion Criteria(Benign Urinary Disease)

-To ensure that alterations in the microbiome observed in bladder cancer patients are unique to this condition, an additional group with benign urinary diseases will be included in the analysis. This group will encompass individuals with renal cysts, benign prostatic obstruction, ureteropelvic or ureteral obstruction undergoing surgical therapy.

Exclusion Criteria:

* NA

Where it's running

• "Regina Elena" National Cancer Institute
  Rome, Italy Recruiting

Study contacts

• Principal investigator: Giuseppe Simone, Doctor — IRCCS National Cancer Institute
• Study coordinator: Giuseppe Simone, Doctor
• Email: giuseppe.simone@ifo.it
• Phone: +39-06-5266.5005

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.